Regulatory Affairs Coordinator

Job Description

1. Oversee and coordinate the registration, renewal, and updating of registrations in all countries where Grin Laboratories holds sanitary registrations.

2. Establish a system for tracking the status of registrations in process with the Regulatory Affairs Chemists.

3. Implement the department's dashboard, as well as conduct regulatory impact analyses, proactively reporting risks to the organization.

4. Implement a document management system to address any business opportunity the company may have, including but not limited to public tenders, private tenders, wholesalers, etc.

5. Request and verify that the designs of printed materials (boxes, labels, instructions, or inserts) correspond to the label designs authorized by COFEPRIS or other regulatory agencies for Grin products. 6. Maintain up-to-date information on Grin Laboratories products (registration, product characteristics, product information, etc.) shared in databases for bidding processes, advertising, pharmacovigilance and technovigilance activities, among others.

7. Contribute to the optimization of area processes by generating new ideas or replicating standardized processes in the evaluation of promotional materials, harmonized artwork, stability programs, and the quality management system.

8. Manage, integrate, review, and/or prepare the administrative-legal, technical (quality), and clinical documentation for the registration, renewal, or modification of Sanitary Registrations for Medicines (including New Molecules) and Medical Devices before COFEPRIS or other regulatory agencies for medicines, medical devices, food supplements, cosmetics, or the resulting classification. 9. Follow up and respond to the warnings issued and manage the administrative-legal, technical and clinical documentation required for obtaining, maintaining and/or modifying the health registrations, by COFEPRIS or other Regulatory Agencies in the field of medicines and medical devices, as well as food supplements.

Qualification and Experience

Bachelor's degree in a Health Sciences field (Pharmaceutical Chemist, Pharmaceutical Chemist, Pharmaceutical Biologist, or related field). Master's degree preferred. Diplomas in regulatory affairs, clinical trials, and drug development phases.

5 years of experience in a similar role within the pharmaceutical industry, specifically in sterile product manufacturing plants.

Competencies